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IRCT20260815070650N1 IRCT 2026-09-20 Shiraz University of Medical Sciences oral Clodamaris in the treatment of chemotherapy-induced mucositis Effectiveness of Coldamaris Oral Spray in Preventing and Reducing the Severity of Oral Mucositis in Children with Acute Lymphoblastic Leukemia Undergoing Chemotherapy A Randomized Controlled Clinical Trial 2026-09-23 anticipated 80 Recruiting https://irct.ir/trial/92493 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This study is a two-arm, parallel, randomized controlled clinical trial with a 1:1 allocation ratio. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive Coldamaris oral spray in addition to standard oral care, while the control group will receive standard oral care alone. Because no placebo is used, participants, parents, and the clinical care team will be aware of treatment allocation. However, the occurrence and severity of oral mucositis will be evaluated by a trained outcome assessor who is blinded to group allocation, Randomization description: Participants will be individually allocated to the intervention and control groups using variable block randomization with a 1:1 allocation ratio. The random allocation sequence will be generated by an independent person who is not involved in patient care using statistical software. Variable block sizes will be used to prevent prediction of future treatment assignments. The allocation sequence will be kept in sequentially numbered, opaque, sealed envelopes. After eligibility confirmation and obtaining informed consent, the responsible person will open the corresponding envelope to determine group allocation. Allocation concealment will be maintained until assignment to the study groups, Blinding description: Because no placebo is used, participants, their parents or legal guardians, the principal investigator, and the clinical care team will not be blinded to group allocation. The outcome assessor responsible for evaluating the occurrence and severity of oral mucositis will be blinded to treatment allocation and will not be involved in participant allocation or intervention delivery. 3 Condition 1: Acute Lymphoblastic Leukemia. Condition 2: Oral Mucositis. Intervention 1: Intervention Description: Participants will receive standard oral care in addition to Coldamaris oral spray containing iota carrageenan. The product used will be Coldamaris Rachenspray mit Carragelose, 20 mL, containing 1.2 mg of iota carrageenan, with approximately 0.14 mL delivered per spray. The intervention will start on the first day of induction chemotherapy. Participants will use two sprays three times daily, for a total of six sprays per day, applied locally to the oral mucosa and posterior pharyngeal wall. The spray will preferably be used after meals and after routine oral care. Participants will be advised to avoid eating, drinking, or rinsing the mouth for 20 minutes after administration. The intervention will continue until the end of the induction phase of chemotherapy, approximately four weeks. The product will be supplied by Tachra Pharmed Company. Intervention 2: Control group: Participants will receive standard oral care according to the hospital protocol. Standard care includes oral hygiene education, mouth rinsing with normal saline or saline plus bicarbonate according to routine ward practice, and supportive care when clinically indicated. Participants in this group will not receive Coldamaris oral spray or any similar preventive topical product. If oral mucositis or other oral complications occur, necessary supportive treatments such as systemic analgesics, topical anesthetics, or nutritional interventions will be provided according to the treating physician's clinical judgment and will be recorded. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data, including baseline variables, intervention-related data, oral mucositis assessments, primary and secondary outcomes, and adverse events, together with the study protocol, statistical analysis plan, informed consent form, final study report, and data dictionary, will be available for sharing. All direct identifiers and information that could reasonably permit participant identification will be removed before sharing. When: Access to the data and study documents will begin six months after publication of the main study results and will remain available for requests for five years following publication of the main results. To whom: Qualified researchers affiliated with universities, research centers, and recognized scientific institutions may request access. Requests from researchers in other organizations may also be considered when they have a clearly defined scientific purpose, meet applicable ethical requirements, and do not present an inappropriate conflict of interest. Conditions: The data and documents may be used only for clearly defined scientific purposes, including secondary analyses, reanalysis of study findings, systematic reviews and meta-analyses, or other relevant scientific research. Applicants must provide a written research objective, research questions, and proposed analysis plan. Commercial use, attempts to reidentify participants, transfer of data to third parties without permission, and use beyond the approved purpose will not be permitted. Ethics approval from the applicant's institution and a data use agreement may be required when applicable. Where to obtain: Requests should be submitted to the principal investigator, Dr. Ali Amanati, Shiraz University of Medical Sciences. The official contact information of the principal investigator provided in the clinical trial registry record will be used for correspondence. How to obtain: Applicants must submit a written request including the researcher's identity and institutional affiliation, the purpose of the request, research question, proposed analysis plan, and any required ethics documentation to the principal investigator. The request will be reviewed by the principal investigator and, when necessary, other members of the research team for scientific merit, ethical considerations, confidentiality, and consistency with the informed consent. A decision will normally be communicated within four weeks. Following approval and completion of any required data use agreement, the approved deidentified data or study documents will be provided electronically through a secure method. Comments: No identifiable participant information will be shared. Data sharing will be subject to the informed consent provisions, ethics committee approval, and applicable regulations of Shiraz University of Medical Sciences.
public Ali Amanati
Shiraz, Farhang Shahr, Station 11, Amir Oncology Hospital
shiraz Iran (Islamic Republic of) 7134814336 +98 71 3212 2430 dr.amanati14@gmail.com Shiraz University of Medical Sciences scientific Ali Amanati
Shiraz, Farhang Shahr, Station 11, Amir Oncology Hospital
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3632 3532 dr.amanati14@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 1 and 18 years Confirmed diagnosis of acute lymphoblastic leukemia by a pediatric hematologist-oncologist Newly diagnosed acute lymphoblastic leukemia and being scheduled to start induction chemotherapy No previous anticancer treatment before enrollment Decision by the treating physician to initiate standard induction chemotherapy Adequate clinical and performance status to tolerate chemotherapy according to the treating physician Written informed consent provided by a parent or legal guardian Age-appropriate assent provided by children aged 7 years or older 1 year 18 months Both Known or uncontrolled diabetes mellitus Absolute neutrophil count below 200 cells per microliter at baseline White blood cell count below 1000 cells per microliter at baseline History of severe hypersensitivity or known allergic reaction to Coldamaris or any of its components Presence of an active severe oral lesion at baseline that interferes with mucositis assessment Active severe oral herpes infection at baseline Extensive or multiple aphthous ulcers at baseline Severe or refractory oral candidiasis at baseline Presence of another concurrent malignancy Presence of a primary immunodeficiency disorder Critical clinical condition at baseline that makes oral examination or administration of the intervention impossible C91.0 K12.3 Acute lymphoblastic leukemia [ALL] Oral mucositis (ulcerative) Prevention N/A Intervention Description: Participants will receive standard oral care in addition to Coldamaris oral spray containing iota carrageenan. The product used will be Coldamaris Rachenspray mit Carragelose, 20 mL, containing 1.2 mg of iota carrageenan, with approximately 0.14 mL delivered per spray. The intervention will start on the first day of induction chemotherapy. Participants will use two sprays three times daily, for a total of six sprays per day, applied locally to the oral mucosa and posterior pharyngeal wall. The spray will preferably be used after meals and after routine oral care. Participants will be advised to avoid eating, drinking, or rinsing the mouth for 20 minutes after administration. The intervention will continue until the end of the induction phase of chemotherapy, approximately four weeks. The product will be supplied by Tachra Pharmed Company. Control group: Participants will receive standard oral care according to the hospital protocol. Standard care includes oral hygiene education, mouth rinsing with normal saline or saline plus bicarbonate according to routine ward practice, and supportive care when clinically indicated. Participants in this group will not receive Coldamaris oral spray or any similar preventive topical product. If oral mucositis or other oral complications occur, necessary supportive treatments such as systemic analgesics, topical anesthetics, or nutritional interventions will be provided according to the treating physician's clinical judgment and will be recorded. Incidence of clinically significant oral mucositis of grade 2 or higher. Timepoint: Before the initiation of chemotherapy and on days 3, 7, 10, 14, and 21 after the start of induction chemotherapy, and whenever clinically significant oral symptoms occur. Method of measurement: Assessment and grading of oral mucositis using the World Health Organization Oral Toxicity Scale. Incidence of severe oral mucositis of grade 3 or 4. Timepoint: Before the initiation of chemotherapy and on days 3, 7, 10, 14, and 21 after the start of induction chemotherapy, and whenever clinically significant oral symptoms occur. Method of measurement: Assessment and grading of oral mucositis using the World Health Organization Oral Toxicity Scale, the National Cancer Institute Common Terminology Criteria for Adverse Events, and the Western Consortium for Cancer Nursing Research Stomatitis Staging System. Tachra Pharmed Approved 2026-08-01 Ethics Committee of Shiraz University of Medical Sciences, School of Medicine Karim Khan Zand Blvd., School of Medicine, Shiraz University of Medical Sciences, Shiraz, Fars, Iran shiraz Fars Iran (Islamic Republic of)